BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.3MM X 12MM LOCKING CORTICAL SCREW

    MDR report key: 14189591 · Received April 22, 2022

    Report

    Report Number
    3025141-2022-00089
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT WAS INSPECTED UNDER MAGNIFICATION. UNDER MAGNIFICATION, THE BATCH NUMBER FOR THE 2.3MM X 12MM LOCKING CORTICAL SCREW (P/N CO-T2312) WAS CONFIRMED AS 203655. UPON INSPECTION, THE FOLLOWING OBSERVATIONS WERE NOTED: THE RETURNED 2.3MM X 12MM LOCKING CORTICAL SCREW SHOWED EXTREME DAMAGE TO THE HEAD OF THE SCREW, WITH THE RECESS BEING COMPLETELY ROUNDED AND DEFORMED. THE LENGTH OF THE SCREW WAS STRIPPED, WITH THE GOLD ANODIZATION WORN OFF OF MANY OF THE THREAD EDGES. THE SCREW WAS ADDITIONALLY BENT AND CURVED AND HAD THICK LAYERS OF SHINY SILVER MATERIAL IN BETWEEN THE THREADS CLOSEST TO THE TIP OF THE SCREW. IT IS POSSIBLE THAT THIS IS FROM THE CROSS-THREADING BETWEEN THE SCREW AND THE THREADS OF THE PLATE. IT WAS NOT POSSIBLE TO DETERMINE WHETHER THE SCREW WAS DAMAGED ENTIRELY DURING THE INSERTION OR REMOVAL OF THE IMPLANTS. THEREFORE, NO DEFINITIVE CONCLUSION CAN BE MADE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN NEEDED TO SWAP A SCREW BECAUSE IT WAS TOO LONG AND WHEN HE ATTEMPTED TO TAKE IT OUT, THE SCREW STRIPPED. THEN WHEN TRYING TO REMOVE THE OTHER 2 SCREWS, THEY STRIPPED, AND THE PHYSICIAN HAD TO IMPROVISE TO GET THE PLATE OUT. THIS ISSUE ADDED AROUND 30 MIN. OR MORE TO THE CASE. AFTER REMOVING THE PLATE, THE PHYSICIAN ATTEMPTED TO GET THE SCREWS OUT, AND THEY SEEMED TO BE COLD WELDED. THIS REPORT IS RELATED TO REPORT NUMBERS 3025141-2022-00088, 3025141-2022-00090, 3025141-2022-00091, AND 3025141-2022-00092 FOR THE OTHER DEVICES INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199779 2.3MM X 12MM LOCKING CORTICAL SCREW SCREW, FIXATION, BONE HWC ACUMED, LLC CO-T2312 203655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown